Treatment With SU11248 in Patients With Neuroendocrine Tumors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00056693 |
Recruitment Status :
Completed
First Posted : March 24, 2003
Last Update Posted : July 21, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuroendocrine Tumors | Drug: Sunitinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 107 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Advanced Unresectable Neuroendocrine Tumor |
Study Start Date : | April 2003 |
Actual Primary Completion Date : | September 2006 |
Actual Study Completion Date : | September 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: A |
Drug: Sunitinib
Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity
Other Name: Sutent, SU011248 |
- Radiographic objective disease response [ Time Frame: From screening until disease progression or discontinuation of study ]
- To assess safety (adverse events and lab abnormalities) [ Time Frame: From screening until patient death or discontinuation of study ]
- To assess patient-reported outcomes and treatment-related symptoms [ Time Frame: From screening until patient death or discontinuation of study ]
- To assess pharmacokinetics and biomarkers [ Time Frame: From screening until patient death or discontinuation of study ]
- To assess overall survival at 1 year [ Time Frame: From screening until patient death or discontinuation of study ]
- To assess other measures of antitumor efficacy including TTP and survival [ Time Frame: From screening until patient death or discontinuation of study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically proven diagnosis of carcinoid tumor or pancreatic islet cell tumor.
- Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
- ECOG performance status 0 or 1
Exclusion Criteria:
- Diagnosis of small-cell carcinoma, pheochromocytoma/paraganglioma, Merkel cell carcinoma, or any other second malignancy within the last 5 years except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
- Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056693
United States, Alabama | |
Pfizer Investigational Site | |
Birmingham, Alabama, United States, 35233 | |
Pfizer Investigational Site | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Pfizer Investigational Site | |
Los Angeles, California, United States, 90033-0800 | |
Pfizer Investigational Site | |
Los Angeles, California, United States, 90033 | |
Pfizer Investigational Site | |
San Francisco, California, United States, 94115-1705 | |
United States, Illinois | |
Pfizer Investigational Site | |
Pinckneyville, Illinois, United States, 62274 | |
United States, Massachusetts | |
Pfizer Investigational Site | |
Boston, Massachusetts, United States, 02114 | |
Pfizer Investigational Site | |
Boston, Massachusetts, United States, 02115 | |
Pfizer Investigational Site | |
Boston, Massachusetts, United States, 02215 | |
United States, Missouri | |
Pfizer Investigational Site | |
St Louis, Missouri, United States, 63110 | |
Pfizer Investigational Site | |
St. Louis, Missouri, United States, 63110 | |
United States, Pennsylvania | |
Pfizer Investigational Site | |
Philadelphia, Pennsylvania, United States, 19111 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
ClinicalTrials.gov Identifier: | NCT00056693 History of Changes |
Other Study ID Numbers: |
RTKC-0511-015 |
First Posted: | March 24, 2003 Key Record Dates |
Last Update Posted: | July 21, 2008 |
Last Verified: | July 2008 |
Neuroendocrine tumor, advanced disease, sunitinib, Phase 2 |
Neuroendocrine Tumors Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Sunitinib Antineoplastic Agents |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |